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Dressing: Frequency of Change and Evaluation of an Antiseptic-Impregnated Catheter Dressing in ICU Patients (DRESSING)

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00417235
First received: December 28, 2006
Last updated: June 13, 2008
Last verified: June 2008
History of Changes
  Purpose

The purpose of this study is to determine whether a catheter dressing every 7th day is not inferior to a catheter dressing every 3 days and if Chlorhexidine impregnated sponges are effective in preventing catheter-related infections in ICUs.


Condition Intervention Phase
Systemic Inflammatory Response Syndrome
Bacteremia
 Device: Chlorhexidine Sponge (Biopatch TM)
Behavioral: 3-day or 7-day catheter dressing frequency
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Dressing: Comparison of 3-Day and 7-Day Catheter Dressing Frequency and Efficacy of Antiseptic Impregnated Dressing in Preventing Catheter-Related Infection in ICU

Resource links provided by NLM:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • Systemic catheter related sepsis as defined by a blinded expert panels to unmask differences between Chlorhexidine dressings and no Chlorhexidine dressings [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Significant catheter culture >=103 cfu/ml for non inferiority between 7 days and 3 day catheter-dressing frequencies [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • catheter related septicemia [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • cutaneous allergy [ Time Frame: 24 hours ] [ Designated as safety issue: Yes ]
  • cost [ Time Frame: within the 60 days after catheter insertion ] [ Designated as safety issue: No ]

Estimated Enrollment: 1600
Study Start Date: January 2007
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
3-days chlorexidrine impregnated sponge
 Device: Chlorhexidine Sponge (Biopatch TM)
dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge
Behavioral: 3-day or 7-day catheter dressing frequency
dressing changes every 7 days versus every 3 days
No Intervention: 3
7-days chlorexidrine impregnated sponge
 Device: Chlorhexidine Sponge (Biopatch TM)
dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge
Behavioral: 3-day or 7-day catheter dressing frequency
dressing changes every 7 days versus every 3 days
No Intervention: 2
3-days without chlorexidrine impregnated sponge
 Device: Chlorhexidine Sponge (Biopatch TM)
dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge
Behavioral: 3-day or 7-day catheter dressing frequency
dressing changes every 7 days versus every 3 days
No Intervention: 4
7 days without chlorexidrine impregnated sponge
 Device: Chlorhexidine Sponge (Biopatch TM)
dressing with chlorexidrine sponge versus dressing without chlorexidrine sponge
Behavioral: 3-day or 7-day catheter dressing frequency
dressing changes every 7 days versus every 3 days

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients older than 18 years
  • with at least a central venous catheter or an arterial catheter
  • whatever the first or subsequent CVC in a same patient
  • in any site of insertion (sub-clavian, jugular or femoral)
  • whatever le CVC is tunnelled or not
  • CVC inserted in the study ICU or immediately before by the intensisvist in the emergency unit or in the operative room,
  • CVC inserted under maximal barrier precautions

Exclusion Criteria:

  • pulmonary artery catheter, haemodialysis/haemodiafiltration CVCs
  • known allergy to chlorhexidine
  • CVC not inserted under maximal barrier precautions
  • Expected duration of CVC for less than 48 hours
  • CVC inserted under emergency conditions
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417235

Locations
France
grenoble university hospital (medical ICU and surgical ICU)
Grenoble, France, 38043
University hospital Bichat Claude Bernard
Paris, France, 75018
Saint Joseph Hospital
Paris, France, 75014
University Hospital Beaujon
Paris, France, 75018
Sponsors and Collaborators
University Hospital, Grenoble
Ministry of Health, France
Investigators
Principal Investigator: jean-francois Timsit University Hospital, Grenoble
Study Chair: jean-christophe Lucet, MD University hospital Bichat, Paris, France
  More Information

Additional Information:
the cover webpage will provide some information about the study status  This link exits the ClinicalTrials.gov site

No publications provided by University Hospital, Grenoble

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: TIMSIT, University Hospital of Grenoble
ClinicalTrials.gov Identifier: NCT00417235     History of Changes
Other Study ID Numbers: 05PHN01
Study First Received: December 28, 2006
Last Updated: June 13, 2008
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Grenoble:
catheter related infection
catheter dressing
prevention
 Chlorhexidine impregnated dressings
Infection
catheterization

Additional relevant MeSH terms:
Bacteremia
Systemic Inflammatory Response Syndrome
Catheter-Related Infections
Bacterial Infections
Sepsis
Infection
Inflammation
Pathologic Processes
Shock
 Anti-Infective Agents, Local
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on May 22, 2013